The following data is part of a premarket notification filed by Delphinus Medical Technologies, Inc with the FDA for Solfvue.
Device ID | K142517 |
510k Number | K142517 |
Device Name: | SolfVue |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth, MI 48170 |
Contact | Andrea N Wallen-gerding |
Correspondent | Andrea N Wallen-gerding DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth, MI 48170 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-08 |
Decision Date | 2014-10-31 |
Summary: | summary |